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Status:

COMPLETED

Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adenocarcinoma of the Pancreas

Recurrent Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying how well RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) works in treating patients with previously treated metastatic pancreatic cancer. RO492...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the 6-month survival of patients with previously treated metastatic pancreas cancer treated with gamma secretase RO4929097. II. To determine the adverse events of...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
  • Not amenable to potentially curative surgical resection
  • At least 1 prior regimen of chemotherapy, preferably gemcitabine-based, for metastatic disease
  • Evidence of disease progression
  • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
  • Available archived tumor tissue (baseline core biopsies or surgical tumor blocks)
  • No diagnosis by fine-needle aspiration only
  • No known brain metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (Karnofsky 70-100%)
  • White blood cell count (WBC) ≥ 3,000/mm³
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin normal
  • Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Willingness to undergo 2 tumor biopsies, if required
  • Fertile patients must use 2 forms of contraception (i.e., barrier contraception and one other method of contraception) ≥ 4 weeks prior to, during, and for ≥ 12 months after completion of therapy
  • Negative pregnancy test
  • Not pregnant or nursing
  • Able to swallow pills
  • No patients with malabsorption syndrome or other condition that would interfere with intestinal absorption
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma secretase inhibitor RO4929097
  • Not serologically positive for hepatitis A, B, or C
  • No history of liver disease, other forms of hepatitis, or cirrhosis
  • No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia despite adequate electrolyte supplementation
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia other than chronic, stable atrial fibrillation
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • No baseline QTcF \> 450 msec (male) or QTcF \> 470 msec (female)
  • No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin or carcinoma in-situ of the uterine cervix
  • No combination antiretroviral therapy for HIV-positive patients
  • Recovered to \< Common Toxicity Criteria for Adverse Effects (NCI CTCAE) grade 2 toxicities from prior therapy
  • More than 3 weeks since prior chemotherapy for metastatic disease (6 weeks for carmustine or mitomycin C)
  • At least 4 weeks since prior radiotherapy
  • Concurrent low-molecular weight heparin (LMWH) or full-dose coumadin allowed
  • International normalized ratio (INR) must be monitored as clinically indicated
  • No other concurrent investigational agents
  • No concurrent strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, including the following:
  • Strong inhibitors: Amiodarone, erythromycin, clarithromycin, grapefruit juice, isoniazid, ketoconazole, itraconazole, or nefazodone
  • Patients taken off strong inhibitors allowed provided they have ≥ 1-week washout period
  • Strong inducers: Carbamazepine, pentobarbital, phenobarbital, phenytoin, Rifabutin, Rifampin, or St. John wort
  • Patients taken off strong inducers allowed provided they have ≥ 2-week washout period
  • No concurrent antiarrhythmics or other medications known to prolong QTc

Exclusion

    Key Trial Info

    Start Date :

    October 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2014

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT01232829

    Start Date

    October 1 2010

    End Date

    May 1 2014

    Last Update

    November 26 2014

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, United States, 80045

    2

    University of Colorado

    Denver, Colorado, United States, 80217-3364

    3

    Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, United States, 21287